Regulatory Labeling Associate
Artech Information System LLC, Spring House, Pennsylvania, United States, 19477
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description T his position is to support the Global Labeling Centre of Excellence (GL COE) Global Labeling Compliance (GLC) group with maintenance of labeling change control records within the TrackWise system to improve data quality and ensure timely completion of milestones.
Job Responsibilities
Correct change control records in the Trackwise system, in accordance with direction provided by GLC colleagues, following naming conventions and according to required timelines.
Set up and run reports in the Trackwise system to assess data completeness of the records.
Manipulate data in MS Excel to identify gaps and issues based on business rules.
Qualifications Required Technical Competencies & Knowledge
A minimum of 2 years’ experience in a highly regulated environment (pharmaceutical, etc.) required.
Knowledge of and experience in the ETS Trackwise Change Control environment or equivalent preferred.
MS Excel skills and comfort with MS Office and Sharepoint.
Effective interpersonal, verbal and written communication skills, in English.
Maintains confidentiality and meets own commitments.
Completes work in a timely, error-free, and consistent manner.
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Job Description T his position is to support the Global Labeling Centre of Excellence (GL COE) Global Labeling Compliance (GLC) group with maintenance of labeling change control records within the TrackWise system to improve data quality and ensure timely completion of milestones.
Job Responsibilities
Correct change control records in the Trackwise system, in accordance with direction provided by GLC colleagues, following naming conventions and according to required timelines.
Set up and run reports in the Trackwise system to assess data completeness of the records.
Manipulate data in MS Excel to identify gaps and issues based on business rules.
Qualifications Required Technical Competencies & Knowledge
A minimum of 2 years’ experience in a highly regulated environment (pharmaceutical, etc.) required.
Knowledge of and experience in the ETS Trackwise Change Control environment or equivalent preferred.
MS Excel skills and comfort with MS Office and Sharepoint.
Effective interpersonal, verbal and written communication skills, in English.
Maintains confidentiality and meets own commitments.
Completes work in a timely, error-free, and consistent manner.
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